Specialist Quality Compliant Breda

Specialist Quality Compliant

The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.

Role Description
As a Specialist Quality Complaints, you will be responsible for to conducts facilitates cross-functional teams to conduct basic and complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.

Responsibilities
– Ensures quality of complaint records, facilitate cross-functional meetings to plan and coordinate the plan for closure of records.
– Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information.      
– Executes against prioritized work plans, quickly escalates issues that could impede the ability to close records according to action plans.
– Maintains compliance with local and global processes, execution of regulatory and SOP requirements.
– Anticipates and prevents potential issues with regulators, provides guidance and technical advice

Requirements
– 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
– Bachelor’s Degree in a Science Field
– Ability to oversee multiple projects simultaneously, ability to successfully manage workload to timelines.
– Familiarity with basic project management tools.
– Ability to negotiate a position after taking feedback from multiple sources.
– Demonstrated ability to consistently deliver on time, and high-quality results.

Other information
Are you interested? Feel free to contact me!